Chelation Therapy Under Scrutiny

A clinical trial suggesting the heart benefits of the controversial treatment draws criticism from the scientific community.

By Bob Grant | November 15, 2012

WIKIMEDIA, WALDSZENENA 10-year, $31.6 million study has found that patients who receive weekly infusions of a chemical that purportedly soaks up metal ions from the blood are less likely to suffer repeat heart attacks. But the trial, which was funded by two National Institutes of Health centers—the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI)—is being criticized by researchers who are taking issue with the study, its investigators, and its funders. The treatment, called chelation therapy, has long been considered a fringe medical procedure, but is popular in the United States, with more than 110,000 patients undergoing the treatment every year. The new trial found that weekly infusions of a chelating agent called salt of ethylenediaminetetraacetic acid lowered the risk of repeat heart attacks in more than 1,700 patients, though chelation therapy has been linked to heart attacks and death in other studies.

Cleveland Clinic cardiologist Steve Nissen has spoken out about the trial's co-investigators, noting that about 24 of them have been disciplined by state medical boards for insurance fraud and providing ineffective treatments, among other missteps. “They offer aromatherapy, crystal therapy, and every imaginable wacky form of medicine,” Nissen told Nature. “You can’t do high-quality research at sites like that. We wasted $30 million and 10 years on an unreliable study.”

Critics also faulted NCCAM, which often justifies its $128 million annual budget by touting its ability to scientifically debunk unproven and unapproved therapies, for funding the study. “Even if you did pristine research under the NCCAM,” Yale University neurologist Steven Novella told Nature, “it’s what you’re studying that is the problem.”

Nissen offered a dire warning if the results of the trial, which were presented at the annual meeting of the American Heart Association earlier this month, are taken seriously. “Public harm is going to come out of this. People are going to get bilked out of a lot of money," he told Nature. "People are going to die."

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My great aunt had a series of ministrokes in the late 80s/early 90s and took chelation because of it. It did seem to help. I always thought it was a pity it wasn't covered under Medicare; it seems to me that any legitimate medical treatment ought to be covered.

The negative reviews of this research is a good example of the scientism passing for science in some circles. Scientism is practiced by alleged scientists who have lost touch with the foundations of science as an open-minded but rigourous and structured system of inquiry, and turned it into a religious belief system in which their ideosyncractic views of what is real are honored and all others are attacked. They should take a history or philosophy of science course to see how often such fanatsism has held back the progress of science.

“They offer aromatherapy, crystal therapy, and every imaginable wacky form of medicine,”

Based on what they DO they say they are incapable of doing quality research ? We know medical doctors such as Lendon Smith were ALSO considered to be criminals because he chose to use vitamins in his treatment of children. When one considers the context of 'insurance fraud' IN the medical profession , it is just who and when THEY decide to proceed with criminal charges. If you 'toe the line' , follow standards of care fairly closely , BUT , if you decide to use other methods , THEN , it seems the wicket becomes sticky. If vanilla smell in an incubator relieves apnea in premature babies , one can believe , aromatherapy .. works.

I struggle to understand how any funded study can proceed without the most rigorous design and supervision being signed off on. Systematic audits should be carried out at regular times, as well as ad hoc, to ensure the validity of the data.

Regardless of the reputation of the research team or lab, this type of scrutiny should have been put in place years ago so that we minimise waste of precious research dollars.

We certainly should not ever get to a point where we get to the end of a $30 million spend and suddenly see flaws in design or method, for example. Too many studies should not even be getting off the ground, so flawed are the methods and the data.

Quite agree! Even if the criticisms of some people involved are themselves valid, it didn't prove the research to be wrong. I've also noted that once a subject/medical treatment or theory has been deemed 'highly controversial' the degree of evidence needed increases vastly beyond what is rational in approximate inverse proportion to the available funding/skilled open minded researchers needed to make headway with it. Any old excuse is wheeled out to attack such a 'controversial' theory and pretty soon one starts to see more errors of a logical nature in the attacks upon it than comming from the supportive literature or arguments. In many cases, in fact there isn't any controversy because the data actually does show the critics to be wrong very conclusively, but that data is itself disregarded for whatever reason, or more often, its simply completely ignored and forgotten.

Since we introduced Chelation Therapy in India at Sibia Medical Centre, Ludhiana, in 1994 we always considered it as a patient proven therapy that has insufficient double blind controlled studies. Our experience of probably over 100,000 intravenous infusions stands testimony to it. We believe that it is near impossible to have such a trial. Even double blind studies in bypass surgery and angioplasty are rare. The mental block against chelation therapy lies in it appearing to be such a simple solution to a complex problem. We welcome anyone to contact us on Mb +91-9814034818 to visit us with an open mind and interview our patients. We have several patients who had no option due to being unfit for surgery, recurrence after bypass, failed bypass and those who could not afford bypass who have responded well to chelation therapy. Specially important is the zero mortality during the procedure. Dr Sibia